CN117045711A - Safflower leisure tablet with high stability and preparation method thereof - Google Patents
Safflower leisure tablet with high stability and preparation method thereof Download PDFInfo
- Publication number
- CN117045711A CN117045711A CN202311176525.6A CN202311176525A CN117045711A CN 117045711 A CN117045711 A CN 117045711A CN 202311176525 A CN202311176525 A CN 202311176525A CN 117045711 A CN117045711 A CN 117045711A
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- Prior art keywords
- parts
- extract
- water
- mixing
- safflower
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
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Abstract
The invention provides a safflower leisure tablet with high stability and a preparation method thereof, and relates to the field of traditional Chinese medicine preparation, wherein the preparation method of the safflower leisure tablet comprises the following steps: extracting volatile oil from angelica, bighead atractylodes rhizome and mint; (2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, radix Paeoniae alba, spina Gleditsiae, and bupleuri radix, extracting with water, and concentrating to obtain extract A; (3) Mixing spina Gleditsiae, poria, and Glycyrrhrizae radix, extracting with water, and concentrating to obtain extract B; (4) Mixing herba Menthae after volatile oil extraction with Carthami flos, extracting with water, and concentrating to obtain extract C; (5) Mixing extract A, extract B and extract C to obtain mixed extract, adding lactose, sodium starch octenyl succinate and D-xylose, drying, granulating, adding magnesium stearate, mixing, tabletting to obtain tablet, and coating. The tablet has good stability and dissolution.
Description
Technical Field
The invention relates to the field of traditional Chinese medicine preparation, in particular to a safflower leisure tablet with high stability and a preparation method thereof.
Background
The safflower Xiaoyao tablet is a liver-soothing and qi-regulating medicine, and the raw materials comprise angelica sinensis, white paeony root, bighead atractylodes rhizome, poria cocos, safflower, spina gleditsiae, bupleurum chinense, peppermint and liquorice, and have the effects of soothing liver, regulating qi and activating blood, and specifically comprises the following documents: tao Guozhi the composition for treating primary dysmenorrhea of girls is prepared from Carthami flos XIAOYAO tablet (56 cases of clinical observations [ J ]. J. Of pediatric traditional Chinese medicine, 2016,12 (2): 4. The composition has remarkable clinical effects and low recurrence rate. Or the safflower ease tablet is used in combination with other medicines, for example, the literature: yuan Yalan A, zheng Qian B, liu Bo A, etc. A clinical effect of the combination of the safflower Xiaoyao tablet and the left thyroxine sodium tablet for treating thyroid nodule with qi stagnation and blood stasis [ J ]. A world traditional Chinese medicine, 2023,18 (4): 5A, which describes that the combination of the safflower Xiaoyao tablet and the left thyroxine sodium tablet is used for treating the patient with thyroid nodule with qi stagnation and blood stasis in perimenopause, has good clinical effect.
In addition, patent CN102204967a discloses a preparation method of safflower leisure tablets, which comprises the following raw materials in parts by weight: 220g-300g of angelica, 220g-300g of white peony root, 220g-300g of bighead atractylodes rhizome, 220g-300g of poria cocos, 30g-70g of safflower, 60g-100g of spina gleditsiae, 220g-300g of bupleurum chinense, 20g-60g of peppermint and 160g-240g of liquorice. The invention mainly improves the preparation method of the safflower leisure tablet, adopts the beta-cyclodextrin inclusion technology on the addition method of the volatile oil, and effectively increases the retention index of the volatile components of the traditional Chinese medicine in the preparation.
The invention discloses a safflower ease preparation for treating hyperplasia of mammary glands, a preparation method and application thereof, and the invention improves the preparation method of the preparation, so that the safflower ease preparation has better treatment effect on hyperplasia of mammary glands, reduces the impurity content in components such as safflower and the like, and improves the efficacy of active ingredients of the safflower ease preparation.
Patent CN110496157a discloses a safflower ease preparation for treating breast cancer, and a preparation method and application thereof, which comprises the following raw materials: 18-67 parts of Chinese angelica, 100-150 parts of white paeony root, 30-55 parts of largehead atractylodes rhizome, 105-135 parts of Indian buead, 110-160 parts of safflower, 20-35 parts of spina gleditsiae, 80-140 parts of bupleurum chinense, 45-85 parts of peppermint and 20-75 parts of liquoric root; the medicine has good curative effect on breast cancer.
However, the solution of the former patent still has a further room for research, and at the same time, the stability is possibly further improved, and the latter two patents focus on the efficacy of the safflower leisure tablet in the aspect of treating breast cancer and hyperplasia of mammary glands, and neither of them performs research on the stability of the safflower leisure tablet.
Aiming at the problems existing in the prior art, it is necessary to find a safflower leisure tablet with high stability and a preparation method thereof.
Disclosure of Invention
Aiming at the problems existing in the prior art, the invention provides the safflower leisure tablet with high stability and the preparation method thereof, and the safflower leisure tablet has good stability and efficacy.
In order to achieve the above purpose, the technical scheme adopted by the invention is as follows:
the invention provides a preparation method of safflower leisure tablets, which comprises the following steps:
(1) Extracting volatile oil from radix Angelicae sinensis, atractylodis rhizoma and herba Menthae;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, radix Paeoniae alba, spina Gleditsiae, and bupleuri radix, extracting with water, and concentrating to obtain extract A;
(3) Mixing spina Gleditsiae, poria, and Glycyrrhrizae radix, extracting with water, and concentrating to obtain extract B;
(4) Mixing herba Menthae after volatile oil extraction with Carthami flos, extracting with water, and concentrating to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding lactose, sodium starch octenyl succinate and D-xylose, drying, granulating, adding magnesium stearate, mixing, tabletting to obtain tablet, and coating.
Further, the extraction in the step (1) adopts a steam distillation method, specifically, the angelica, the bighead atractylodes rhizome and the mint are crushed and then soaked in water for 1.5-3 hours, and the volatile oil rectifier is used for carrying out the in-water distillation until the volatile oil is not increased.
Further, the safflower leisure tablet comprises the following raw materials in parts by weight: 220-280 parts of angelica, 220-280 parts of white paeony root, 220-280 parts of bighead atractylodes rhizome, 220-280 parts of poria cocos, 30-72 parts of safflower, 56-104 parts of spina gleditsiae, 220-280 parts of bupleurum chinense, 18-55 parts of mint and 150-220 parts of liquorice.
Preferably, the safflower leisure tablet comprises the following raw materials in parts by weight: 260 parts of angelica, 260 parts of white peony root, 260 parts of bighead atractylodes rhizome, 260 parts of poria cocos, 40 parts of safflower, 81 parts of spina gleditsiae, 260 parts of bupleurum chinense, 36 parts of peppermint and 180 parts of liquorice.
Further, the weight ratio of the spina gleditsiae in the step (2) to the spina gleditsiae in the step (4) is 1-3:1. Preferably 2:1.
Further, the water extraction in the steps (2) and (4) is specifically that water is added to heat up to 65-70 ℃, the temperature is kept for 10-20min, the water extraction liquid is obtained by filtering, the repeated steps are carried out for 2-3 times, and the water extraction liquid is combined.
Further, the water extraction in the step (3) is specifically that water is added, the temperature is raised to 75-85 ℃, the temperature is kept for 15-25min, the water extraction liquid is obtained by filtering, the repeated steps are carried out for 2-3 times, and the water extraction liquid is combined.
Further, the water adding amount of the water extraction in the steps (2) - (4) is 5-6 times of the weight of the medicinal materials.
Further, the concentration ratio in each of the steps (2) to (4) is 1.8 to 2.5 times.
Further, the weight ratio of lactose, sodium starch octenyl succinate, D-xylose and the mixed extract in the step (5) is 30-35:5-10:8-15:30-40. Preferably 35:8:9:35.
Further, the magnesium stearate in the step (5) is added in an amount of 0.8-1.2% of the total weight of the mixed extract.
Further, the coating in the step (5) is specifically performed by using a coating liquid, wherein the coating liquid is obtained by mixing hydroxypropyl methylcellulose with water, and the coating liquid is uniformly sprayed on the plain tablets during coating.
Further, the invention provides the safflower leisure tablet prepared by the preparation method.
The invention has the technical effects that:
the volatile oil is extracted by processing the crude drugs of the safflower ease tablet, and meanwhile, specific active ingredients of the crude drugs are extracted in steps in a merging mode, so that the efficacy of the safflower ease tablet is effectively improved by utilizing the interaction of the active ingredients after extraction in the extraction process. Meanwhile, by adding other auxiliary materials such as lactose, sodium starch octenyl succinate, D-xylose and the like, the stability of the tablet can be effectively enhanced, and meanwhile, the excellent effect and dissolution rate of the safflower leisure tablet can be ensured.
Detailed Description
Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention.
Before the embodiments of the invention are explained in further detail, it is to be understood that the invention is not limited in its scope to the particular embodiments described below; it is also to be understood that the terminology used in the examples of the invention is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the invention.
Where numerical ranges are provided in the examples, it is understood that unless otherwise stated herein, both endpoints of each numerical range and any number between the two endpoints are significant both in the numerical range. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
It should be noted that the raw materials used in the present invention are all common commercial products, and therefore the sources thereof are not particularly limited.
Example 1
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Crushing 220 parts of angelica, 220 parts of bighead atractylodes rhizome and 18 parts of mint, soaking in water for 1.5 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, 220 parts of radix Paeoniae alba, 28 parts of spina Gleditsiae and 220 parts of bupleuri radix, adding water 5 times of the weight of the materials, heating to 65deg.C, maintaining the temperature for 20min, filtering to obtain water extractive solution, repeating for 2 times, mixing the water extractive solutions, and concentrating 1.8 times to obtain extract A;
(3) Mixing 28 parts of spina gleditsiae, 220 parts of poria cocos and 150 parts of liquorice, adding water which is 5 times of the weight of the medicinal materials, heating to 75 ℃, preserving heat for 25min, filtering to obtain water extract, repeating for 2 times, combining the water extract, and concentrating 1.8 times to obtain an extract B;
(4) Mixing herba Menthae after volatile oil extraction with 30 parts of Carthami flos, adding water 5 times of the weight of the medicinal materials, heating to 65deg.C, maintaining for 20min, filtering to obtain water extractive solution, repeating for 2 times, mixing water extractive solutions, and concentrating 1.8 times to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding lactose, sodium starch octenyl succinate and D-xylose (weight ratio of lactose, sodium starch octenyl succinate, D-xylose and mixed extract is 30:5:8:30), drying, granulating, adding magnesium stearate 0.8% of total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
Example 2
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Pulverizing 280 parts of Chinese angelica, 280 parts of bighead atractylodes rhizome and 55 parts of mint, soaking in water for 3 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, 280 parts of radix Paeoniae alba, 78 parts of spina Gleditsiae and 280 parts of bupleuri radix, adding water with a weight 6 times of that of the medicinal materials, heating to 70deg.C, maintaining for 10min, filtering to obtain water extractive solution, repeating for 3 times, mixing the water extractive solutions, and concentrating for 2.5 times to obtain extract A;
(3) Mixing 26 parts of spina gleditsiae, 280 parts of poria cocos and 220 parts of liquorice, adding water which is 6 times of the weight of the medicinal materials, heating to 85 ℃, preserving heat for 15min, filtering to obtain water extract, repeating for 3 times, combining the water extract, and concentrating for 2.5 times to obtain an extract B;
(4) Mixing herba Menthae after volatile oil extraction with 72 parts of Carthami flos, adding water 6 times of the weight of the medicinal materials, heating to 70deg.C, maintaining for 10min, filtering to obtain water extractive solution, repeating for 3 times, mixing water extractive solutions, and concentrating 2.5 times to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding lactose, sodium starch octenyl succinate and D-xylose (weight ratio of lactose, sodium starch octenyl succinate, D-xylose and mixed extract is 35:10:15:40), drying, granulating, adding magnesium stearate 1.2% of total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
Example 3
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Pulverizing 260 parts of Chinese angelica, 260 parts of bighead atractylodes rhizome and 36 parts of mint, soaking in water for 2 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, 260 parts of radix Paeoniae alba, 54 parts of spina Gleditsiae and 260 parts of bupleuri radix, adding water with a weight 6 times of that of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing the water extractive solutions, and concentrating for 2 times to obtain extract A;
(3) Mixing 27 parts of spina gleditsiae, 260 parts of poria cocos and 180 parts of liquorice, adding water which is 6 times of the weight of the medicinal materials, heating to 80 ℃, preserving heat for 20min, filtering to obtain water extract, repeating for 3 times, combining the water extract and concentrating for 2 times to obtain an extract B;
(4) Mixing herba Menthae after volatile oil extraction with 40 parts of Carthami flos, adding water 6 times of the weight of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing water extractive solutions, and concentrating 2 times to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding lactose, sodium starch octenyl succinate and D-xylose (weight ratio of lactose, sodium starch octenyl succinate, D-xylose and mixed extract is 35:8:9:35), drying, granulating, adding magnesium stearate 1% of total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
Comparative example 1
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Pulverizing 260 parts of Chinese angelica, 260 parts of bighead atractylodes rhizome and 36 parts of mint, soaking in water for 2 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, 260 parts of radix Paeoniae alba, 54 parts of spina Gleditsiae and 260 parts of bupleuri radix, adding water with a weight 6 times of that of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing the water extractive solutions, and concentrating for 2 times to obtain extract A;
(3) Mixing 27 parts of spina gleditsiae, 260 parts of poria cocos and 180 parts of liquorice, adding water which is 6 times of the weight of the medicinal materials, heating to 80 ℃, preserving heat for 20min, filtering to obtain water extract, repeating for 3 times, combining the water extract and concentrating for 2 times to obtain an extract B;
(4) Mixing herba Menthae after volatile oil extraction with 40 parts of Carthami flos, adding water 6 times of the weight of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing water extractive solutions, and concentrating 2 times to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding lactose (weight ratio of lactose to mixed extract is 52:35), drying, granulating, adding magnesium stearate 1% of total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
Comparative example 2
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Pulverizing 260 parts of Chinese angelica, 260 parts of bighead atractylodes rhizome and 36 parts of mint, soaking in water for 2 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, 260 parts of radix Paeoniae alba, 54 parts of spina Gleditsiae and 260 parts of bupleuri radix, adding water with a weight 6 times of that of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing the water extractive solutions, and concentrating for 2 times to obtain extract A;
(3) Mixing 27 parts of spina gleditsiae, 260 parts of poria cocos and 180 parts of liquorice, adding water which is 6 times of the weight of the medicinal materials, heating to 80 ℃, preserving heat for 20min, filtering to obtain water extract, repeating for 3 times, combining the water extract and concentrating for 2 times to obtain an extract B;
(4) Mixing herba Menthae after volatile oil extraction with 40 parts of Carthami flos, adding water 6 times of the weight of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing water extractive solutions, and concentrating 2 times to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding sodium starch octenyl succinate (weight ratio of sodium starch octenyl succinate to mixed extract is 52:35), drying, granulating, adding magnesium stearate 1% of total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
Comparative example 3
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Pulverizing 260 parts of Chinese angelica, 260 parts of bighead atractylodes rhizome and 36 parts of mint, soaking in water for 2 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, 260 parts of radix Paeoniae alba, 54 parts of spina Gleditsiae and 260 parts of bupleuri radix, adding water with a weight 6 times of that of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing the water extractive solutions, and concentrating for 2 times to obtain extract A;
(3) Mixing 27 parts of spina gleditsiae, 260 parts of poria cocos and 180 parts of liquorice, adding water which is 6 times of the weight of the medicinal materials, heating to 80 ℃, preserving heat for 20min, filtering to obtain water extract, repeating for 3 times, combining the water extract and concentrating for 2 times to obtain an extract B;
(4) Mixing herba Menthae after volatile oil extraction with 40 parts of Carthami flos, adding water 6 times of the weight of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing water extractive solutions, and concentrating 2 times to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding D-xylose (weight ratio of D-xylose to mixed extract is 52:35), drying, granulating, adding magnesium stearate 1% of total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
Comparative example 4
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Pulverizing 260 parts of Chinese angelica, 260 parts of bighead atractylodes rhizome and 36 parts of mint, soaking in water for 2 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, herba Menthae with 260 parts of radix Paeoniae alba, 260 parts of Poria, 40 parts of Carthami flos, 81 parts of spina Gleditsiae, 260 parts of bupleuri radix and 180 parts of Glycyrrhrizae radix, adding 6 times of water, heating to 80deg.C, maintaining for 50min, filtering to obtain water extractive solution, repeating for 3 times, mixing the water extractive solutions, and concentrating 2 times to obtain extract;
(3) Mixing the extract with lactose, sodium starch octenyl succinate, and D-xylose (weight ratio of lactose, sodium starch octenyl succinate, D-xylose and extract is 35:8:9:35), drying, granulating, adding magnesium stearate 1% of total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
Comparative example 5
A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Pulverizing 260 parts of Chinese angelica, 260 parts of bighead atractylodes rhizome and 36 parts of mint, soaking in water for 2 hours, and distilling in water by using a volatile oil rectifier until volatile oil is not increased;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, 260 parts of radix Paeoniae alba, 54 parts of spina Gleditsiae and 260 parts of bupleuri radix, adding water with a weight 6 times of that of the medicinal materials, heating to 70deg.C, maintaining for 15min, filtering to obtain water extractive solution, repeating for 3 times, mixing the water extractive solutions, and concentrating for 2 times to obtain extract A;
(3) Mixing 27 parts of spina gleditsiae, 260 parts of poria cocos and 180 parts of liquorice, adding water which is 6 times of the weight of the medicinal materials, heating to 80 ℃, preserving heat for 20min, filtering to obtain water extract, repeating for 3 times, combining the water extract and concentrating for 2 times to obtain an extract B;
(4) Mixing 40 parts of safflower and peppermint, adding water which is 6 times of the weight of the medicinal materials, heating to 70 ℃, preserving heat for 15min, filtering to obtain water extract, repeating for 3 times, combining the water extract and concentrating for 2 times to obtain an extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, drying, granulating, adding magnesium stearate 1% of the total weight of the mixed extract, mixing, tabletting to obtain tablet, and coating.
1. Stability test of safflower Xiaoyao tablet
1. Test article: safflower leisure tablets of examples 1-3 and comparative examples 1-5 were ground to obtain powders;
2. stability acceleration test: the test sample is placed for 1 month and 3 months under the conditions that the temperature is 40+/-2 ℃ and the relative humidity is 75+/-5%.
And (3) measuring the change condition of the glycyrrhizin content in the safflower leisure tablets in the acceleration test of 0 month, 1 month and 3 months based on the glycyrrhizin content.
3. Chromatographic conditions and system suitability test: octadecylsilane chemically bonded silica is used as a filler; acetonitrile is taken as a mobile phase A, 0.05% phosphoric acid solution is taken as a mobile phase B, and gradient elution is carried out according to the specifications in the following table; the detection wavelength was 237nm. The number of theoretical plates should be not less than 5000 calculated according to the glycyrrhizin peak.
4. Preparation of a control solution: taking appropriate amount of glycyrrhizin reference substance, precisely weighing, and adding 70% ethanol to obtain 20 μg solution containing glycyrrhizin per 1 mL.
5. Preparation of test solution: taking about 0.2g of the powder of the test sample, precisely weighing, placing in a conical bottle with a plug, precisely adding 100mL of 70% ethanol, sealing, weighing, performing ultrasonic treatment (power is 250W, frequency is 40 kHz) for 30 minutes, cooling, weighing again, supplementing the lost weight with 70% ethanol, shaking uniformly, filtering, and taking the subsequent filtrate.
6. Assay: respectively precisely sucking 10 μl of each of the reference solution and the sample solution, and injecting into a liquid chromatograph for measurement.
TABLE 1 variation of glycyrrhizin content
According to the table, after the safflower leisure tablets of each embodiment of the invention are subjected to accelerated test for 1 month and 3 months, the liquiritin content in the tablets is stable as a whole, namely, the tablets have good stability.
2. Dissolution test
1. Test article: examples 1-3 and comparative examples 1-5 were safflower leisure tablets.
2. Preparing a reference substance solution: taking appropriate amount of glycyrrhizin reference substance, precisely weighing, and adding 70% ethanol to obtain solution containing 15 μg of glycyrrhizin per 1 mL.
3. Assay: the second method is measured by referring to 0931 of the general rule of four parts of the edition of Chinese pharmacopoeia 2020. The method specifically comprises the following steps: putting 4g of a test sample into 900mL of water, sampling 20mL at the time of 5min, 10min, 20min, 30min and 60min respectively at 100r/min, filtering by a 0.45 mu m membrane, discarding 10mL of primary filtrate, taking the continuous filtrate as a test sample solution, measuring the absorbance of each solution at 362nm by using an ultraviolet-visible spectrophotometry, and calculating the dissolution rate to obtain the following table:
TABLE 2 dissolution rate variation
According to the table, the safflower leisure tablets of each embodiment of the invention can be dissolved out rapidly at 5min, and reach a dissolution platform at 10min, so that the tablet has good dissolution rate.
Finally, it should be noted that the above description is only for illustrating the technical solution of the present invention, and not for limiting the scope of the present invention, and that the simple modification and equivalent substitution of the technical solution of the present invention can be made by those skilled in the art without departing from the spirit and scope of the technical solution of the present invention.
Claims (10)
1. A preparation method of safflower leisure tablets is characterized in that: the method comprises the following steps:
(1) Extracting volatile oil from radix Angelicae sinensis, atractylodis rhizoma and herba Menthae;
(2) Mixing the volatile oil extracted radix Angelicae sinensis, atractylodis rhizoma, radix Paeoniae alba, spina Gleditsiae, and bupleuri radix, extracting with water, and concentrating to obtain extract A;
(3) Mixing spina Gleditsiae, poria, and Glycyrrhrizae radix, extracting with water, and concentrating to obtain extract B;
(4) Mixing herba Menthae after volatile oil extraction with Carthami flos, extracting with water, and concentrating to obtain extract C;
(5) Mixing extract A, extract B and extract C to obtain mixed extract, adding lactose, sodium starch octenyl succinate and D-xylose, drying, granulating, adding magnesium stearate, mixing, tabletting to obtain tablet, and coating.
2. The method of manufacturing according to claim 1, characterized in that: the safflower leisure tablet comprises the following raw materials in parts by weight: 220-280 parts of angelica, 220-280 parts of white paeony root, 220-280 parts of bighead atractylodes rhizome, 220-280 parts of poria cocos, 30-72 parts of safflower, 56-104 parts of spina gleditsiae, 220-280 parts of bupleurum chinense, 18-55 parts of mint and 150-220 parts of liquorice.
3. The preparation method according to claim 2, characterized in that: the safflower leisure tablet comprises the following raw materials in parts by weight: 260 parts of angelica, 260 parts of white peony root, 260 parts of bighead atractylodes rhizome, 260 parts of poria cocos, 40 parts of safflower, 81 parts of spina gleditsiae, 260 parts of bupleurum chinense, 36 parts of peppermint and 180 parts of liquorice.
4. The method of manufacturing according to claim 1, characterized in that: the weight ratio of the spina gleditsiae in the step (2) to the spina gleditsiae in the step (3) is 1-3:1.
5. The method of manufacturing according to claim 1, characterized in that: the water extraction in the steps (2) and (4) is specifically that water is added to raise the temperature to 65-70 ℃, the temperature is kept for 10-20min, the water extraction liquid is obtained by filtering, the process is repeated for 2-3 times, and the water extraction liquid is combined.
6. The method of manufacturing according to claim 1, characterized in that: the water extraction in the step (3) is specifically that water is added, the temperature is raised to 75-85 ℃, the temperature is kept for 15-25min, the water extraction liquid is obtained by filtering, the water extraction liquid is repeated for 2-3 times, and the water extraction liquid is combined.
7. The method of manufacturing according to claim 1, characterized in that: the concentration times in the steps (2) - (4) are all 1.8-2.5 times.
8. The method of manufacturing according to claim 1, characterized in that: the weight ratio of lactose, sodium starch octenyl succinate, D-xylose and the mixed extract in the step (5) is 30-35:5-10:8-15:30-40.
9. The method of manufacturing according to claim 1, characterized in that: the addition amount of the magnesium stearate in the step (5) is 0.8-1.2% of the total weight of the mixed extract.
10. The safflower leisure tablet prepared by the preparation method of any one of claims 1 to 9.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202311176525.6A CN117045711A (en) | 2023-09-13 | 2023-09-13 | Safflower leisure tablet with high stability and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202311176525.6A CN117045711A (en) | 2023-09-13 | 2023-09-13 | Safflower leisure tablet with high stability and preparation method thereof |
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| CN202311176525.6A Pending CN117045711A (en) | 2023-09-13 | 2023-09-13 | Safflower leisure tablet with high stability and preparation method thereof |
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